Table Of ContentPHARMACOPOEIA
OF THE PEOPLE'S REPUBLIC OF CHINA
(2005)
Volume II
PHARMACOPOEIA
OF THE PEOPLE'S REPUBLIC OF CHINA
(2005)
Volume II
Chinese Pharmacopoeia Commission
People's Medical Publishing House
PHARMACOPOEIA OF THE PEOPLE'S REPUBLIC OF CHINA
ISBN 7-117-06983-x
(2005)
Volume II
This pharmacopoeia is the English version edited from Pharmacopoeia of the
People's Republic of China 2005. The Chinese edition is approved by the 9 _ _ _ >
State Food and Drug Administration of the People's Republic of China to be
effective from July 1, 2005, in accordance with the official document
GSYJZ (2005) 234.
(CIP) IM
n & m ^ mn A R M i U M i, 2005.9
ISBN 7-117-06983-X
n. a... in. s-2005-^3:
W.R921.2
^afe^ffl^tlCIP^M^^ (2005) m 078111-^
Compiled by The State Pharmacopoeia Commission of P. R. China
All rights reserved
Executive Editors: CAO Jinhua GUO Xianghui SONG Xiuquan TANG Xiaoyu WANG He
Cover Designer: GUO Miao
Format Designer: MA Yu
Executive Correctors CHANG Shuyu SONG Peiru REN Shuwen WU Xiaocui
:
ISBN 7-117-06983-X/R • 6984
Copyright © 2005 by People's Medical Publishing House
Published by People's Medical Publishing House
3,3Qu, Fang Qun Yuan, Fang Zhuang, Fengtai Dist., Beijing, China, 100078
Printed in the People's Republic of China
Contents
Membership of the 8th Pharmacopoeia Commission of the People's Republic of China H
Editorial Board of Pharmacopoeia of the People's Republic of China (2005) Volume H Ml
Preface 1
History of the Pharmacopoeia of the People's Republic of China XI
New Admissions XIX
Omissions or Adjustments included in Volume H (2000 Edition) XM
General Notices XW
Monographs Part I 1
Monographs Part H 909
Appendices A-l
Index 1-1
Membership of the 8th Pharmacopoeia Commission
of the People's Republic of China
Chairman;
ZHENG Xiaoyu (M&M)
Vice Chairmen:
JIANG Zuojun SHAO Mingli (MAL) LI Zhenji
YUAN Yonglin
Members of the Executive Cor
ZHENG Xiaoyu JIANG Zuojun f fW SHAO Mingli (SPffiSr)
LI Zhenji (^HW) YUAN Yonglin REN Dequan (ftflfcR)
NG Guowei C^SIE) CAO Wenzhuang (ffX£) BAI Huiliang (&JK6.)
ZHANG Zhijun XIE Xiaoyu WANG Guorong (£021)
ZHOU Fucheng WANG Ping JIN Shaohong
ZHOU Haijun ZHAO Kai XIAO Peigen
WANG Yongyan ZHOU Chaofan TIAN Songjiu (fflil^L)
ZHU Junren ( f i t) JIN Youyu ( ^ t i f) YANG Zhongyuan
LEI Dianliang (WKS.)
Members; (Arranged alphabetically according to the names)
AN Huamin ( ^ R) AN Jingxian BAI Huiliang (fijRfe)
BAO Jiake (Ml?f4) BI Kaishun i ^ WO BI Shengli (^JftflJ)
BI Xiuling CAI Baochang ( U SD CAI Shaoqing (H^W)
CAO Baocheng CAO Caifang (WJfcSf) CAO Wenzhuang (WlfcflE)
CAO Xuetao ( W W) CHE Qingming CHEN Daofeng (|gagl$)
CHEN Gang CHEN Jianxing (l&MftO CHEN Kaixian (|^0l5fe)
CHEN Keji d&nTJ|) CHEN Shengdi CHEN Shiming (Kstftfg)
CHEN Shiping CHEN Wei (|^it) CHEN Weifeng Q$ftt$)
CHEN Woju ( « *) CHEN Xiyuan CHEN Zhensheng (|jjH§|£)
CHENG Pengfei (@||T<) CHENG Yaqin (MBW) CHU Jiayou (ill&)
DENG Bingxu DING Jianmi ( T ^) DONG Guanmu
DONG Xiao'ou DONG Yi DU Pinghua ( f ± W)
DU Zhanming (tt£BJ!) DUO Jie FAN Jifen
FENG Fansheng (^H^) FENG Guokang (i^Bli) FENG Guoping O^g^)
FENG LI MM) FU Wen (jfjt) FU Xueren
GAN Shaobo (TOffi) GAO Feng GAO Qipin (SSfn)
GAO Runlin (ffiM) GAO Xuemin (fl^ft) GE Sangbazhu
GE Sangsuolang GONG Qinyan (Jt^^) GU Jianren (JIJHiA)
GU Niufan GUO Chengming ($&J&BJ) GUO De'an
GUO Dianwu HA Mulati • WU Pu'er (Pfryfcfit
HE Jiangong ) HE Mingxin (fafggf) HE Xun (fnfiSj)
HOU Huimin HOU Shixiang (#tft#) HU Changqin
HUANG Fei (J|§g) HUANG Luqi (ftflSBif) HUANG Meisheng (fUD^O
JI Shaoliang C ^ g .) JI Shen JI Wei ( W)
JI Yang (m&l) JI Yubin (m^W JIA Tianzhu (H^ctt)
JIANG Ning JIANG Xiongping (#!£¥) JIANG Zhuming
JIANG Zuojun (f|#®) JIN Shaohong JIN Youyu
JIN Yulan KANG Shuanglong (JUM) KUANG Haixue
LAI Shilong (ffctftfe) LAO Jiahua LEI Dianliang ( f l |)
LI Bo LI Changling LI Dakui
LI Defu LI Guangrong (^itW) LI Jingyun
LI Lianda LI Maoliang (^Sjggfe) LI Mingfu (^BJg)
.LI Xudong (^JfliK) LI Zhenji (m LIANG Guodong (JgStSO
LIANG Zujiang LIAO Ltitan (0MM) LIN Ruichao
LIN Sanren (flcHt) LIN Xiangtong LIN Xiaojun
LIN Yongqi ( # 7 ^) LIN Zhibin LING Dakui
LIU Baokui LIU Gengtao (^JHfW) LIU Shulin (*!]##)
LIU Tiegang LIU Wenying LIU Wuxia (M*FW
LIU Xiaolin LIU Youning (M X t) LU Aiying (fiMW
LU Bin (Rftfc) LU Guibao (SiiaS) LU Huiwen flfflKlfc)
LU Jing (##) LUO Ailun LUO Guo'an
LUO Zhifu (W^W LUO Zhuoya MA Dalong (Bj^zjt)
MAI Maitihasimu (X^fl^Sff^) NA Shengsang NAN Nan (pHif)
NI Daoming (flKtW) NI Madunzhu NIE Xiaochun (g/h#)
NIU Ben PAN Weifang PEI Xuetao (H®f#)
PU Xufeng QI Ping QI Zhongtian OS+ffl)
QI Zibai QIAN Weiqing QIAN Xiaohong
QIAN Zhongzhi C^®,!!) QIN Shaorong QIU Shilin
RAO Chunming REN Dequan (ft 11*30 REN Jinbin
REN Meimei (jfgcgc) RUAN Li (Bn^J) SANG Guowei (&SHD
SHA Zhenfang (tyWf) SHAN Yuandong (#.jK09O SHANG Hong (fail)
SHAO Mingli SHE Qing (£}*) SHEN Beifen
SHEN Huifeng (tfcMM) SHEN Pingniang SHEN Xinliang (tt'C?&)
SHENG Shuguang SU Demo SUN Jiling
SUN Piaoyang (JNRJ&) SUN Shuchun SUN Wenji (Jjvjt*)
SUN Yan ( 3® TANG Jiaqi (JfgOg) TANG Qiaoying
TANG Qiujin ( J f M) TANG Renjiu (Jf A%) TANG Yuantai
TIAN Ruihua TIAN Songjiu (ffl^fcjL) TONG Chunrong (&##)
TU Pengfei (JtlUS) WANG Bailu WANG Chunlong ( £ # #)
WANG Fu WANG Guorong WANG Guozhi ( l i f e)
WANG Heng WANG Hua WANG Jian
WANG Jingxing (i'HHS) WANG Junzhi (i^jfe) WANG Muzou (iHtP)
WANG Ningli (i^flj) WANG Ningsheng ( £ f 4) WANG Pengfu (£f|g)
IV
WANG Ping (£¥) WANG Qingguo (3E&H) WANG Shengqi (ZE^Jg)
WANG Wentao WANG Xiang ( £ #) WANG Xiaoliang (iBjgg.)
WANG Xiaoning (BE/hr) WANG Xiaoping (igg^F) WANG Yinghua
WANG Yiting WANG Yongming ( £ 7 ^) WANG Yongxian (£|§$fc)
WANG Yongyan WANG Youchun (3E|fi#) WANG Zhengtao
WANG Zhiqing WEI Shuli WENG Weiliang
WU Yonglin (#Mc#) XIA Zhenmin (JUHR> XIANG Ping (JjR¥)
XIAO Peigen XIE Guilin (iftjfcflO XIE Kongbiao (i|f?L#)
XIE Peishan (i|fi&llj) XIE Shichang (iftttl) XIE Xiaoyu
XU Anlong XU Bingjiu (^HtSX) XU Huinan (#illt)
XU Jianguo XU Kangsen XU Lianlian
XU Lianying (&SI3S) XU Qingfeng (ifrWH) XU Shisong
XU Yucong (&&]») XU Zhikai (tfcifegll) XU Zuoliang (Wfeg.)
YAN Shiyun ( f2^) YANG Huichuan (f^OD YANG Liang (WM)
YANG Shilin YANG Weiyan YANG Xiuwei
•YANG Yaoting YANG Yonghong YANG Zhongyuan
YAO Damu YAO Naili (ftJ^L) YAO Shouzhuo (j&W)
YAO Xinsheng (jjfc®r£> YE Yunfei (BfS^) YIN Chunhua
YIN Hongzhang YING Xianyong (#5feH) YOU Kai (j»jjm)
YU Dequan YU Li (jfci) YU Mosong (^Ife)
YU Ruying ( # «) YU Yongming (^Icfg) YU Yongxin
YUAN Qinsheng YUAN Tianxi YUAN Wenwei ( ^ 3 $)
YUAN Yonglin ZENG Ming (#BJ) ZENG Yixin (i^$r)
ZHANG Bochong (MJS) ZHANG Boli (3TOL) ZHANG Chengui
ZHANG Guangwen (MltX) ZHANG Hanming (&IX.BJ) ZHANG Huayuan
ZHANG Kejian (3££JB) ZHANG Liqun ZHANG Manlai (5fc}f3fc)
ZHANG Peipei ZHANG Qiming (&JgBj) ZHANG Qingbo
ZHANG Qiusheng ZHANG Shibin (Jfrfcfcft) ZHANG Wei
ZHANG Xiulan ZHANG Zhijun ZHANG Zhirong
ZHANG Zhongming (&&BJ) ZHANG Yu (Jfci?) ZHAO Jindong
ZHAO Kai (MIB) ZHAO Lanfeng ZHAO Ming (j&H)
ZHAO Weiliang ZHAO Zhilan ZHEN Yongsu (S&jfc)
ZHENG Shurong ZHENG Xiaoli ( M M) ZHENG Xiaoyu (8&RH)
ZHONG Bohua (fMQ^) ZHONG Dafang ZHONG Guoying (#|B^)
ZHOU Chaofan (JSIjgJl) ZHOU Fucheng (MJ&) ZHOU Furong (Jiff^)
ZHOU Guisheng ZHOU Guo'an (JS|g$) ZHOU Guoxiong (JH|gi£)
ZHOU Haijun ZHOU Jianping (JS|jg¥0 ZHOU Kai (ffiiUt)
ZHOU Wenquan (j^jtlD ZHOU Xiafen (JUg^) ZHU Jiabi
ZHU Junren (it^t) ZHU Liping (fcHflO ZHU Xuejun
ZHU Yan (3US) ZHU Yanmin (flcgR) ZHU Zhifeng
ZHUANG Hui ( M) ZOU Jieming (IP^BJ)
Deceased Members: LI Anjuan YU Guodian ( ^ g ^)
V
Editorial Board of Pharmacopoeia of the People's
Republic of China (2005) Volume I
Editor-in-Chief
;
SANG Guowei (j JJH)
Execute Associate Editor-in-Chief
:
WANG Guorong
Associate Editors-in-Chief:
YANG Zhongyuan WANG Ping ( i ^) JIN Shaohong ( ^ M)
CHEN Jianxing (|$M?T) ZHANG Peipei ZHANG Shibin
Members of Editorial committee: (Arranged alphabetically according to the names)
CHEN Gang CHEN Guiliang CHEN Jianxing (MsMfi1)
CHEN Zhensheng GAO Liqin (ifc&JRl) GU Lisu
HAN Peng (Hit) HONG Liya (#tflj«) HU Changqin (iHlfj)
JIANG Dianzhuo JIANG Yingqiao (tt&ft) JIN Shaohong
LI Huiyi (^MX) LIU Ling (MW LUO Zhuoya
NAN Nan (jtfit) WANG Fei (££||0 WANG Ping (£¥>
XU Huayu ( | f l) XU Mingdi XU Zhili
YANG Yongjian YANG Zhongyuan (®#7C) YIN Hua
ZHANG Peipei ZHANG Shibin ZHANG Xiaohong (M&&D
ZHAO Ming (MHJ) ZHOU Lichun ZHOU Yi (Jl'f&)
ZUO Shu
Co-workers: (Arranged alphabetically according to the names)
CHEN Ying ( «) TANG Sufang YANG Huaxin (#ffc®r)
YANG Yali (Mfij) YAO ZHI YIN Lihui (f*5p]#£)
IX
Preface
This edition of the Pharmacopoeia of the People's Republic of China (known as the Chinese Phar?nacopoeia
2005 or in abbreviation as Ch. P 2005) has been prepared in accordance with the principles and designed
plan decided by the Eighth Chinese Pharmacopoeia Commission and accomplished with the effort made by
Commission members and its Secretariat over more than two years. The Chinese Pharmacopoeia 2005
adopted by the Executive Commission of the Chinese Pharmacopoeia Commission is approved for
implementation by the State Food and Drug Administration of China. This is the eighth edition of Chinese
Pharmacopoeia since the founding of the People's Republic of China.
The Chinese Pharmacopoeia 2005 has been considerably revised and improved in General Notices,
Requirements of Monographs, General Requirements for Preparations in Appendices and new testing
methods, etc. Based on the introduction of advanced technology and experimental methods widely
adopted in China and abroad, the contents of Appendices are revised by and large in consistence with those
nowadays applied internationally for drug quality control. On the premise that every effort should be made
to follow the principle of "safety for use, reliability of therapeutic effect, feasibility of processes,
controllability of manufacturing quality and perfection of specification", the monographs admitted in the
Pharmacopoeia on the whole reflect the actual clinical use of drugs in China. Furthermore, stylistic rules
and layout, wording, units, and symbols, etc. have also been standardized.
The Chinese Pharmacopoeia 2005 is published in three volumes. Volume I contains monographs of
Chinese materia medica and prepared slice, vegetable oil/fat and its extract, Chinese traditional patent
medicines, single ingredient of Chinese crude drug preparations etc. ; Volume H deals with monographs
of chemical drugs, antibiotics, biochemical preparations, radiopharmaceuticals and excipients for
pharmaceutical use; Volume HI contains biological products. The Requirements for Biologies of the
People's Republic of China is now incorporated into the Chinese Pharmacopaeia for the first time. Based
on the characteristics and the needs of improvement of Chinese traditional medicines, chemical drugs and
biological products, the research work and the studies are carried out in an active way on drug standards
and methodology. At the same time, great efforts are made to unify the national drug standards and to
bring them in line with the international standards progressively. In addition, emphasis have been put to
harmonization in Appendices of different volumes of Pharmacopoeia, to a sound connection between
individual monographs and the relevant appendices, and to the standardization of text wording so as to
make this edition more precise and better structured.
The increase of the number of monographs in the Chinese Pharmacopoeia 2005 is obvious which contains
up to 3214 monographs of drugs, with 525 new admissions in total. Volume I contains 1146
monographs, with 154 new admissions and 453 revised; Volume H deals with 1967 monographs, with
327 new admissions and 522 revised; Volume EQ[ contains 101 monographs, with 44 new admissions and
57 revised. 9 monographs adopted in the Chinese Pharmacopoeia 2000 are not admitted in this edition and
1
